Alpha Tau Medical Ltd. (DRTS), a clinical-stage oncology therapeutics company, on Thursday announced FDA clearance for an enrollment of additional patients and expansion of U.S. testing sites in the REGAIN study for the use of Alpha-DaRT in treating Glioblastomas.
Alpha-DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to deliver radium-224 sourced intratumorally, facilitating the destruction of the tumor by alpha-emitting atoms. Recurrent glioblastoma patients show very low response rates to existing treatments, and the Alpha-DaRT technology shows potential in improving precision of treating these tumors. The therapy was previously granted a Breakthrough Device designation by the FDA in 2021.
The REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial is an open-label, single-arm interventional study evaluating Alpha-DaRT in treating recurrent glioblastomas.
The agency approved the enrollment of seven additional patients based on positive data from three patients treated in the REGAIN study between December 2025 and March 2026. Interim results showed a 100% local disease control, and a 67% complete response rate, as defined by the response assessment in neuro-oncology (RANO) criteria.
The safety profile of the drug was also found to be manageable, as one grade 3 severe adverse event (SAE) was reportedly fully resolved.
The FDA also authorized the addition of two leading U.S. academic cancer centers to join the REGAIN trial as participating sites. The company stated that this was an important step to broaden access to the therapy and to add multidisciplinary neuro-oncology expertise to the program.
DRTS closed Thursday at $9.68, up 4.76%. In the pre-market, shares are trading at $9.89, up 2.17%.
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